[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44636-44639]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0049]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Reporting Harmful and 
Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke 
Under the Federal Food, Drug, and Cosmetic Act

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under Paperwork 
Reduction Act of 1995.

DATES: Fax written comments on the collection of information by August 
29, 2012.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-NEW and 
title ``Reporting Harmful and Potentially Harmful Constituents in 
Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and 
Cosmetic Act.'' Also include the FDA docket number found in brackets in 
the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
[email protected].

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

Reporting Harmful and Potentially Harmful Constituents in Tobacco 
Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic 
Act--(OMB Control Number 0910-NEW)

    On June 22, 2009, the President signed the Family Smoking 
Prevention and Tobacco Control Act (Public Law 111-31) into law. This 
law amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 
grants FDA authority to

[[Page 44637]]

regulate the manufacture, marketing, and distribution of tobacco 
products to protect public health generally and to reduce tobacco use 
by minors. Section 904(a)(3) of the FD&C Act (21 U.S.C. 387d(a)(3)) 
requires each tobacco product manufacturer or importer, or an agent, to 
begin reporting to FDA no later than June 22, 2012, ``all constituents, 
including smoke constituents, identified by [FDA] as harmful or 
potentially harmful to health in each tobacco product, and as 
applicable in the smoke of each tobacco product.'' Reports must be by 
the brand and by quantity in each brand and subbrand. Section 904(c)(1) 
of the FD&C Act states that manufacturers of tobacco products not on 
the market as of June 22, 2009, must also provide information 
reportable under section 904(a)(3) at least 90 days prior to 
introducing the product into interstate commerce.
    FDA has taken several steps to identify harmful and potentially 
harmful constituents (HPHCs) to be reported under sections 904(a)(3) 
and (c)(1) of the FD&C Act, including issuing a final guidance 
discussing FDA's current thinking on the meaning of ``harmful and 
potentially harmful constituent'' in the context of implementing the 
HPHC list requirement (76 FR 5387, January 31, 2011). The guidance is 
available on the Internet at http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm241339.htm. In addition, in 
the Federal Register of April 3, 2012 (77 FR 20034), FDA published a 
notice (the HPHC list notice) announcing the established list of HPHCs 
as required by section 904(e) of the FD&C Act and describing the 
criteria we used in identifying the HPHCs for the established list. 
Previously, FDA sought comment on both the criteria that would be used 
to identify HPHCs for the established list and a list of chemicals and 
chemical compounds that met the proposed criteria.
    In the Federal Register of April 3, 2012 (77 FR 20030), FDA 
announced the availability of a draft guidance entitled ``Guidance for 
Industry: Reporting Harmful and Potentially Harmful Constituents in 
Tobacco Products and Tobacco Smoke Under Section 904(a)(3) of the 
Federal Food, Drug, and Cosmetic Act'' (904(a)(3) draft guidance) 
discussing the information to be reported on HPHCs in tobacco products 
and tobacco smoke under sections 904(a)(3) and (c)(1) of the FD&C Act. 
The 904(a)(3) draft guidance discusses, among other things: The 
statutory requirement for testing and reporting quantities of HPHCs, 
who tests and reports quantities of HPHCs to FDA, what HPHCs will be 
the focus of FDA enforcement at this time, when reports are submitted 
to FDA, what information is reported to FDA, and how the reports should 
be submitted to FDA. The 904(a)(3) draft guidance notifies 
manufacturers and importers that, at this time, while industry is 
developing laboratory capacity to comply with section 904(a)(3) of the 
FD&C Act, FDA does not intend to enforce the statutory requirement to 
submit quantities of all constituents identified by FDA as HPHCs by 
June 22, 2012, where manufacturers or importers complete testing and 
reporting for an abbreviated list of HPHCs as set forth in the 
904(a)(3) draft guidance. In particular, at this time, for products 
that were first marketed before June 22, 2012, FDA does not intend to 
enforce the section 904(a)(3) requirement to test and report quantities 
of all HPHCs on FDA's established list where: (1) A manufacturer or 
importer (or agents thereof), other than a small tobacco product 
manufacturer, submits quantities of the HPHCs on an abbreviated list 
described in the guidance for all of its products, by brand and 
subbrand, no later than September 22, 2012 or (2) a small tobacco 
product manufacturer (or agents thereof) submits quantities of HPHCS on 
the abbreviated list for all of its products, by brand and subbrand, by 
December 22, 2012. In addition, for products first marketed on or after 
June 22, 2012, the 904(a)(3) draft guidance explains that FDA does not 
intend, at this time, to enforce the requirement in section 904(c)(1) 
of the FD&C Act to test and report quantities of all HPHCs on FDA's 
established list for products not previously on the market if a 
manufacturer or importer reports quantities for the abbreviated list of 
HPHCs at least 90 days prior to marketing the product in the United 
States. The 904(a)(3) draft guidance explains that, at this time, FDA 
intends to enforce the HPHC reporting requirements with respect to 
manufacturers of finished tobacco products for consumer use--
cigarettes, smokeless tobacco, and roll-your-own tobacco--and not with 
respect to manufacturers and importers of other products, such as 
components sold to manufacturers or consumers for incorporation into 
finished products.
    The purpose of the proposed information collection is for FDA to 
collect statutorily mandated information regarding HPHCs in tobacco 
products and tobacco smoke, by quantity in each brand and subbrand. The 
904(a)(3) draft guidance provides an abbreviated list of HPHCs on which 
FDA intends to focus enforcement at this time for each of the 
following: Cigarette smoke, smokeless tobacco products, and roll-your-
own tobacco and cigarette filler.
    To facilitate the submission of HPHC information, FDA has developed 
Form 3787 in both paper and electronic formats. Manufacturers or 
importers, or an agent, may submit information either electronically or 
in paper format. The FDA eSubmitter tool provides electronic forms to 
streamline the data entry and submission process for reporting HPHCs. 
Users of eSubmitter may also populate an Excel file and import data 
into eSubmitter. FDA also provides paper forms for the submission of 
section 904(a)(3) reports. FDA placed draft copies of the paper forms 
and screen shots of the electronic form and spreadsheet in this docket. 
Whether respondents decide to submit reports electronically or on 
paper, each form provides instructions for filling out and submitting 
HPHC information to FDA. The forms contain fields for company 
information, product information, and HPHC information (including the 
specific HPHCs identified in the 904(a)(3) draft guidance).
    The Federal Register notice announcing the availability of the 
904(a)(3) draft guidance included a 60-day notice requesting public 
comment on the proposed collection of information. FDA received 16 
comments that were PRA-related, including but not limited to the 
following issues:
     Suggestions to enhance the quality, utility, and clarity 
of the information to be collected (i.e., comments specific to FDA's 
eSubmitter tool and paper forms);
     Cost associated with the collection of information to 
comply with section 904(a)(3) of the FD&C Act, particularly for small 
tobacco product manufacturers; and
     Use of the proposed information collection, especially 
because specific test methods are not prescribed to determine HPHC 
quantities.
    Section 904(a)(3) of the FD&C Act requires HPHC testing and 
reporting. We have stated that we intend to exercise enforcement 
discretion for manufacturers who test for 20 rather than 93 HPHCs at 
this time. In addition, we have recognized that small tobacco product 
manufacturers are likely to rely on contract testing laboratories and 
intend to exercise enforcement discretion for those who submit 
quantities of HPHCs 6 months after the statutory deadline (i.e., 
December 22, 2012), and 3 months after submissions by other tobacco 
product manufacturers. Our abbreviated list of HPHCs, along with the 
timeframes described in the

[[Page 44638]]

draft guidance, represent a reasonable approach to implementing section 
904(a)(3) of the FD&C Act.
    Based on comments received, FDA has revised the instructions for 
FDA Form 3787 to explain that if the HPHC quantity is below the limit 
of detection or limit of quantitation, zero should be entered in the 
space identified for form. We have also made minor cosmetic changes to 
clarify instructions and to allow accurate data entry. FDA has not 
revised the burden estimate for this collection of information.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
      Information collected          Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
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            Part 1--Section 904(a)(3) of the FD&C Act (Annualized estimate of one-time reporting) \2\
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1. Reporting of Manufacturer/
 Importer Company and Product
 Information by Completing
 Submission Forms
    Cigarette...................             120           10.10           1,212            2              2,424
    Roll-Your-Own...............              46            3.22             148            2                296
    Smokeless...................             200            1.44             288            2                576
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           3,296
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2. Testing of HPHC Quantities in Products
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    Cigarette Filler............             120           10.1            1,212            9.42          11,417
    Roll-Your-Own...............              46            3.22             148            9.42           1,394
    Smokeless...................             200            1.44             288           12.06           3,473
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          16,284
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3. Testing of HPHC Quantities in Mainstream Smoke
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    Cigarette: International                 120           10.1            1,212           23.64          28,652
     Organization for
     Standardization (ISO)
     Regimen....................
    Cigarette: Health Canada                 120           10.1            1,212           23.64          28,652
     Regimen....................
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............          57,304
                                 -------------------------------------------------------------------------------
            Total Section         ..............  ..............  ..............  ..............          76,884
             904(a)(3)
             Annualized One-Time
             Burden.............
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             Part 2--Reporting of Section 904(c)(1) New Products (15% of One-Time Burden Totals) \3\
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1. Reporting of Manufacturer/Importer Company and Product Information by Completing Submission Forms
----------------------------------------------------------------------------------------------------------------
    Cigarette...................              18           10.10             182            2                364
    Roll-Your-Own...............               7            3.22              23            2                 46
    Smokeless...................              30            1.44              43            2                 86
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............             496
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2. Reporting of HPHC Quantities in Products
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    Cigarette Filler............              18           10.1              182            9.42           1,714
    Roll-Your-Own...............               7            3.22              23            9.42             217
    Smokeless...................              30            1.44              43           12.06             519
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           2,450
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3. Reporting of HPHC Quantities in Mainstream Smoke
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    Cigarette: ISO Regimen......              18           10.1              182           23.64           4,302
    Cigarette: Health Canada                  18           10.1              182           23.64           4,302
     Regimen....................
                                 -------------------------------------------------------------------------------
        Total...................  ..............  ..............  ..............  ..............           8,604
                                 -------------------------------------------------------------------------------
            Total Section         ..............  ..............  ..............  ..............          11,550
             904(c)(1) Burden...
                                 -------------------------------------------------------------------------------
                Total Reporting   ..............  ..............  ..............  ..............          88,434
                 Burden Hours...
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ One-time actual first year burden hours have been annualized over the 3-year OMB period of approval to avoid
  over counting the burden each year.
\3\ Annual new product reporting under section 904(c)(1) of the FD&C Act is estimated to be 15 percent of the
  annualized one-time burden.


[[Page 44639]]

    FDA estimates the one-time reporting burden for this guidance would 
be 230,652 hours during the first year for section 904(a)(3) of the 
FD&C Act reporting plus ongoing annual burden of 11,550 hours for 
section 904(c)(1) reporting. The burden estimate for this collection of 
information includes the time it will take to read the guidance 
document, test the products, and prepare the HPHC report.
    To avoid overcounting the one-time reporting burden, FDA has 
annualized the one-time burden over the 3-year expected OMB period of 
approval. The annualized one-time burden of 76,884 hours is located in 
part one of table 1 of this document, and includes burden for 
collections of information gathered under section 904(a)(3) of the FD&C 
Act. The total annual burden for this collection of information is 
estimated to be 88,434 hours, which is the annualized one-time burden 
estimate for section 904(a)(3) of the FD&C Act associated with the 
submission of HPHC reports and the annual burden estimate for section 
904(c)(1). Table 1 of this document estimates 366 respondents will 
submit HPHC reports on a one-time basis. Table 1 of this document 
addresses the time required for manufacturers and importers to report 
their company information. We estimate that the burden is no more than 
2 hours per response to report company and product information, 
regardless of whether the paper or electronic form (Form FDA 3787) is 
used. This estimate is not dependent on product type, so the estimated 
burden is the same for cigarettes, roll-your-own tobacco, and smokeless 
tobacco products. We also estimate that 3,636 cigarette subbrands, 445 
roll-your-own tobacco subbrands, and 861 smokeless tobacco subbrands 
(4,942 total subbrands) must comply with section 904(a)(3) of the FD&C 
Act. Therefore, the total annualized burden for reporting company and 
product information is 3,296 hours.
    Table 1 of this document also addresses the time required for 
manufacturers and importers to report quantities of HPHCs in their 
products. The burden hour estimates include the time needed to test the 
tobacco products, draft testing reports, draft the report for FDA, and 
submit the report to FDA. For cigarette filler, smokeless, and roll-
your-own products, we estimate the burden to test the product, draft 
testing reports, draft the report for FDA, and submit the report to FDA 
to be 16,284 annualized burden hours. The burden for each product type 
reflects our estimate of the burden to test the tobacco products (i.e., 
carry out laboratory work).
    In addition to addressing the time required to report quantities of 
HPHCs in tobacco products, table 1 of this document addresses the time 
required for manufacturers and importers to report quantities for HPHCs 
in cigarette smoke. The burden estimates include testing the tobacco 
products, drafting testing reports, drafting the report for FDA, and 
submitting the report to FDA. We estimate the annualized burden for 
this section to be 57,304 hours. The annualized burden reflects our 
estimate of the burden to test the tobacco products (i.e., carry out 
laboratory work). The burden estimate assumes that manufacturers and 
importers report HPHC quantities in cigarette mainstream smoke 
according to the two recommended smoking regimens. The total annualized 
burden for part one of table 1 (section 904(a)(3) reporting) is 76,884 
hours.
    Table 1 of this document also contains estimates for new product 
information received annually under section 904(c)(1) of the FD&C Act. 
Manufacturers and importers must report HPHC information under section 
904(c)(1) of the FD&C Act at least 90 days prior to delivery for 
introduction into interstate commerce. We estimate that approximately 
15 percent of FDA currently regulated tobacco products in any given 
year will require submission of this information. The estimated total 
annual burden for section 904(c)(1) of the FD&C Act is 11,550 hours, 
which includes reporting manufacturer/importer company and product 
information, reporting HPHC quantities in products, and reporting HPHC 
quantities in mainstream smoke.
    The estimated total annual burden for the reporting of HPHC under 
section 904(a)(3) and (c)(1) of the FD&C Act is 88,434 hours, which 
includes the section 904(a)(3) annualized reporting burden plus the 
section 904(c)(1) annual reporting burden.
    We have not estimated any capital costs because we do not believe 
there are any capital costs associated with this collection. However, 
you may comment on any specific capital costs that you have identified.

    Dated: July 24, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18442 Filed 7-27-12; 8:45 am]
BILLING CODE 4160-01-P